Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-28 @ 4:36 PM
Study NCT ID:
NCT02695550
Status:
UNKNOWN
Last Update Posted:
2017-03-09
First Post:
2016-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000715567', 'term': 'conteltinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-08', 'studyFirstSubmitDate': '2016-02-23', 'studyFirstSubmitQcDate': '2016-02-25', 'lastUpdatePostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)', 'timeFrame': '28 days', 'description': 'Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-707 in ALK-positive non-small cell lung cancer (NSCLC) patients. Cycle = 28 days'}, {'measure': 'Frequency of adverse events/serious adverse events', 'timeFrame': 'Up to 24 months', 'description': 'Characterization of the safety and tolerability of CT-707 as determined by changes in laboratory values and electrocardiograms'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR) - Phase I', 'timeFrame': 'Up to 24 month', 'description': 'Preliminary measure of anti-tumor activity of CT-707'}, {'measure': 'Progression free survival (PFS) per RECIST v1.1 - Phase I', 'timeFrame': 'Up to 24 months', 'description': 'Preliminary measures of anti-tumor activity of CT-707'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 24 months', 'description': 'Preliminary measure of anti-tumor activity of CT-707'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '36424628', 'type': 'DERIVED', 'citation': 'Xing P, Zhao Q, Zhang L, Wang H, Huang D, Hu P, Sun Y, Shi Y. Conteltinib (CT-707) in patients with advanced ALK-positive non-small cell lung cancer: a multicenter, open-label, first-in-human phase 1 study. BMC Med. 2022 Nov 23;20(1):453. doi: 10.1186/s12916-022-02646-0.'}, {'pmid': '30381078', 'type': 'DERIVED', 'citation': 'Liang C, Zhang N, Tan Q, Liu S, Luo R, Wang Y, Shi Y, Han X. CT-707 Overcomes Resistance of Crizotinib through Activating PDPK1- AKT1 Pathway by Targeting FAK. Curr Cancer Drug Targets. 2019;19(8):655-665. doi: 10.2174/1568009618666181031152140.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase I study of the ALK/FAK/Pyk2 inhibitor CT-707 in patients with ALK-positive non-small cell lung cancer.\n\nThe purpose of the study is to determine the MTD/RP2D of CT-707 and evaluate whether CT-707 is safe and has beneficial effects in ALK-positive advanced non-small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must be diagnosed with ALK-positive advanced NSCLC. The tumor must be ALK-positive as determined by ALK rearrangement in ≥15% of cells (as measured by FISH using the Vysis break-apart ALK probe) or by using the Ventana ALK IHC test. The analysis may be performed locally.\n\nEastern cooperative oncology group (ECOG) performance status ≤ 2. Measurable disease as per RECIST v1.1\n\nAvailability of tumor sample:\n\nExclusion Criteria:\n\nPatients with symptomatic central nervous system (CNS) metastases who are neurologically unstable or require increasing doses of steroids or local CNS-directed therapy to control their CNS disease Impaired cardiac function or any clinically significant cardiac disease Patients with abnormal laboratory values during screening and on day 1 of pre-dose Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of CT-707 Patient has a history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02695550', 'briefTitle': 'Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centaurus Biopharma Co., Ltd.'}, 'officialTitle': 'Study of Safety, Efficacy and Pharmacokinetics of CT-707 in Patients With ALK-positive Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CT-707-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-707', 'description': 'ALK-positive non-small cell lung cancer resistant to Crizotinib treatment', 'interventionNames': ['Drug: CT-707']}], 'interventions': [{'name': 'CT-707', 'type': 'DRUG', 'armGroupLabels': ['CT-707']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuankai Shi, M.D.', 'role': 'CONTACT', 'email': 'syuankaipumc@126.com', 'phone': '86(10)67781331'}], 'facility': 'Cancer Hospital of Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yong Peng, Dr.', 'role': 'CONTACT', 'email': 'ypeng@centaurusbio.com', 'phone': '86(10)88858866'}], 'overallOfficials': [{'name': 'Yuankai Shi, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Hospital of Chines Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centaurus Biopharma Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}